A traditional Chinese medicine composition for treating rhinitis and a preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine composition technology, and discloses a traditional Chinese medicine composition for treating rhinitis and its preparation method. The active ingredients and their weight ratios in this composition are as follows: 5-15 parts of Gleditsia sinensis, 0.1-0.5 parts of artificial musk, 6-13 parts of Saposhnikovia divaricata, 7-14 parts of Angelica dahurica, 8-12 parts of Magnolia biondii, 6-10 parts of Coptis chinensis, 8-10 parts of catechu, 4-8 parts of Perilla frutescens, 7-10 parts of Sophora japonica, 7-10 parts of Polygonatum sibiricum, 1-5 parts of Pueraria lobata, and 1-4 parts of Artemisia annua. This traditional Chinese medicine composition has a unique and reasonable formulation, a safe and reliable preparation method, significant therapeutic effects, no adverse reactions, and a good effect on improving nasal abnormalities, showing broad application prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and particularly relates to a traditional Chinese medicine composition for treating rhinitis and its preparation method. Background Technology

[0002] Allergic rhinitis (AR), also known as allergic rhinitis, is one of the most common chronic diseases in the world. It is a non-infectious chronic inflammatory disease of the nasal mucosa, primarily mediated by IgE, that occurs in atopic individuals after exposure to allergens. Common clinical symptoms include paroxysmal recurrent nasal congestion, copious clear nasal discharge, nasal itching, and sneezing, which may be accompanied by a decreased sense of smell. It severely disrupts patients' work, study, quality of life, and mental well-being. Its global incidence rate is as high as 10%-20%, and the affected population is gradually increasing. Clinical treatment often involves antihistamines, leukotriene inhibitors, and corticosteroids. Patients often experience recurrent attacks, making it difficult to cure. Western medicine treatments are prone to adverse reactions and drug resistance, leading to poor treatment outcomes. In traditional Chinese medicine, AR falls under the category of "nasal congestion." Traditional Chinese medicine believes that the occurrence of AR is related to multiple factors; the nose is the orifice of the lungs, and lung qi deficiency and cold can lead to symptoms such as a decreased sense of smell and clear nasal discharge. Traditional Chinese medicine (TCM) treatment for acute rheumatoid arthritis (AR) often follows the principles of warming the lungs and dispelling cold, strengthening the spleen and replenishing qi, tonifying the kidneys and consolidating yang, and dispelling wind and opening the orifices. It is characterized by syndrome differentiation and treatment with few side effects.

[0003] Many traditional Chinese medicine compositions for treating rhinitis are disclosed in the prior art. For example, patent number "CN120771221A" discloses "A Traditional Chinese Medicine Composition for Treating Rhinitis," which includes: Platycodon grandiflorus, bitter almond, dried tangerine peel, immature bitter orange peel, aster tataricus, ephedra, trichosanthes kirilowii, fritillaria thunbergii, licorice, and loquat leaf. While this composition claims to significantly relieve sneezing symptoms caused by allergic rhinitis, reduce serum histamine and specific IgE levels, and improve the severity of nasal mucosal lesions, the above-mentioned technical solutions lack reliable clinical trial data, the compatibility needs improvement, and the incidence of adverse reactions is unknown.

[0004] For example, CN117883542A discloses a rhinitis preparation, its preparation method, and its application. The raw materials include the following components in parts by weight: Magnolia biondii 20-50 parts, Rehmannia glutinosa 2-10 parts, Aconitum carmichaelii 2-20 parts, Cinnamomum cassia 2-20 parts, Schizonepeta tenuifolia 2-20 parts, Astragalus membranaceus 15-50 parts, Xanthium sibiricum 6-50 parts, Scutellaria baicalensis 6-30 parts, Stemona japonica 8-50 parts, Saposhnikovia divaricata 10-50 parts, Platycodon grandiflorus 5-30 parts, Dioscorea opposita 10-30 parts, Prunus armeniaca 5-30 parts, Angelica dahurica 5-50 parts, Atractylodes macrocephala 5-30 parts, Zingiber officinale 2-10 parts, Paeonia lactiflora 5-30 parts, and Cinnamomum cassia 2-10 parts. However, the formula of this traditional Chinese medicine composition is too complex.

[0005] Therefore, providing better-formulated and more effective traditional Chinese medicine compositions is particularly important in the clinical use of medications for allergic rhinitis. Summary of the Invention

[0006] The purpose of this invention is to develop a traditional Chinese medicine composition for treating rhinitis and its preparation method. This traditional Chinese medicine composition has a unique and reasonable formulation, a safe and reliable preparation method, and significant therapeutic effects with no adverse reactions.

[0007] To achieve the above-mentioned objectives, the technical solution of this invention is as follows: This invention provides a traditional Chinese medicine composition for treating rhinitis. The formula and proportions of the traditional Chinese medicine composition are as follows: 5-15 parts of Gleditsia sinensis, 0.1-0.5 parts of artificial musk, 6-13 parts of Saposhnikovia divaricata, 7-14 parts of Angelica dahurica, 8-12 parts of Magnolia biondii, 6-10 parts of Coptis chinensis, 8-10 parts of catechu, 4-8 parts of Perilla frutescens, 7-10 parts of Sophora japonica, 7-10 parts of Polygonatum sibiricum, 1-5 parts of Pueraria lobata, and 1-4 parts of Artemisia annua.

[0008] Preferred Option 1: The formula and weight ratio of the traditional Chinese medicine composition are as follows: 10 parts of Gleditsia sinensis, 0.3 parts of artificial musk, 9 parts of Saposhnikovia divaricata, 9 parts of Angelica dahurica, 9 parts of Magnolia biondii, 8 parts of Coptis chinensis, 8 parts of catechu, 6 parts of Perilla frutescens, 8 parts of Sophora japonica, 8 parts of Polygonatum sibiricum, 3 parts of Pueraria lobata, and 3 parts of Artemisia annua.

[0009] Preferred Option 2: The formula of the traditional Chinese medicine composition is further divided into the following weight proportions: 8 parts of Gleditsia sinensis, 0.1 parts of artificial musk, 11 parts of Saposhnikovia divaricata, 11 parts of Angelica dahurica, 10 parts of Magnolia biondii, 7 parts of Coptis chinensis, 8 parts of catechu, 7 parts of Perilla frutescens, 8 parts of Sophora japonica, 9 parts of Polygonatum sibiricum, 4 parts of Pueraria lobata, and 1 part of Artemisia argyi.

[0010] Furthermore, excipients are added to the traditional Chinese medicine composition to prepare a conventional drug dosage form.

[0011] Furthermore, the excipients include microcrystalline cellulose, kaolin, menthol, soap clay, talc, etc.

[0012] Furthermore, the dosage form of the traditional Chinese medicine composition is a topical preparation, including any one of powder or spray powder.

[0013] The present invention also provides a method for preparing the traditional Chinese medicine composition for treating rhinitis, wherein the raw medicinal materials are dried at low temperature and preliminarily pulverized; all the medicinal materials are pulverized again by ultra-micro pulverization, graded and screened, and the medicinal material powder in the range of 45-150μm is selected; the medicinal material powder is mixed and homogenized according to the above proportion, and sterilized to obtain the traditional Chinese medicine composition of the present invention.

[0014] As a preferred embodiment of the present invention, the target particle size is ≥800 mesh after further crushing.

[0015] As a preferred embodiment of the present invention, the raw materials are first dried at a low temperature of ≤60°C, and then initially pulverized at a temperature of ≤40°C.

[0016] As a preferred embodiment of the present invention, the control parameters for ultrafine grinding include: ultrafine grinding under the conditions of a classifying wheel frequency of 18-25Hz, a feeding speed of 3-5kg / h, and a grinding pressure of 0.7-0.8MPa.

[0017] As a preferred embodiment of the present invention, the control parameters for mixing and homogenization include: loading coefficient 60%-70%, mixing time: 30-60 minutes.

[0018] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating rhinitis.

[0019] The preferred dosage form of the traditional Chinese medicine composition of this invention is a topical formula for rhinitis. Its core pathogenesis is the obstruction of nasal passages by wind-heat and damp-toxins, which may also be accompanied by blood stasis and heat. The treatment principle focuses on dispelling wind and opening the nasal passages, clearing heat and drying dampness, and detoxifying and dispersing nodules, while also cooling the blood and protecting the body's vital energy. Formula Explanation: Division of ruler, minister, assistant, and envoy: The principal herb – the main force in attacking pathogens, directly targeting the site of the disease; Gleditsia sinensis: It is pungent, salty and warm in nature. Its pungent and dispersing power is extremely strong, and it can "dispel wind and heat" and "open the nasal passages and eliminate phlegm". In external prescriptions, it is used as the chief herb. It uses its strong penetrating and opening power to powerfully open the nasal passages and expel the evil qi such as wind, dampness, phlegm and heat that are congested in the sinuses, thus opening the door for the whole prescription.

[0020] Artificial musk: It is pungent and warm in nature, with a penetrating aroma. It possesses great potency, effectively opening nasal passages, clearing blockages, promoting blood circulation, and dispersing stagnation. It can guide other medicines directly to the affected area, penetrating the nasal mucosal barrier, making it a key medicine for clearing nasal passages and refreshing the mind. When combined with soapberry, the two work synergistically to overcome the core problem of nasal obstruction.

[0021] Assistant herbs – herbs that assist the principal herbs and enhance their therapeutic effects; Fangfeng (Saposhnikovia divaricata): It is pungent, sweet, and slightly warm. It is a "moisturizer among wind-dispelling drugs" and is good at dispelling wind and relieving exterior symptoms. It can assist the chief drug in expelling wind evils that are entrenched in the head, face, and nasal passages.

[0022] Angelica dahurica: pungent and warm in nature, aromatic and reaching upwards, it effectively clears nasal passages and is a key herb for relieving pain and draining purulent nasal discharge. It can both assist the principal herb in clearing the nasal passages and directly act on headaches and purulent nasal discharge caused by nasal congestion.

[0023] Magnolia biondii: Magnolia biondii is the dried flower bud of plants such as Magnolia denudata and Magnolia officinalis, belonging to the Magnoliaceae family. It possesses pharmacological effects such as anti-inflammatory, anti-allergic, antibacterial, and antioxidant properties. The volatile oils and lignans in Magnolia biondii can inhibit the release of histamine from mast cells, thus reducing allergic reactions. It can also inhibit various inflammatory factors and reduce nasal mucosal swelling. Its volatile oil components can stimulate the nasal mucosa, producing a feeling of contraction and nasal opening, thus improving ventilation.

[0024] Coptis chinensis: extremely bitter and cold, it excels at clearing heat and drying dampness, purging fire and detoxifying. When nasal congestion presents with symptoms of damp-heat and fire toxins such as yellow and turbid purulent nasal discharge and redness and swelling of the nasal mucosa, Coptis chinensis can directly suppress the fire and clear the internal damp-heat, making it an important component in clearing away pathogenic factors.

[0025] Adjuvant medicines – synergistically treat both symptoms and symptoms, restraining imbalances; Catechu: Bitter, astringent, and cooling. Its functions include astringing dampness, promoting wound healing, and stopping bleeding. When the nasal mucosa is chronically inflamed, it's like having internal "sores." Catechu can astringe excess secretions (dampness) and promote the repair of damaged mucosa.

[0026] Perilla: It is pungent and warm, and can relieve exterior syndromes and dispel cold, as well as regulate qi and relieve chest tightness. In this formula, its qi-regulating function helps to resolve qi stagnation and assist in opening the orifices; its pungent and dispersing nature can also help dispel exterior pathogens such as Saposhnikovia divaricata.

[0027] Sophora japonica flowers: bitter and slightly cold in nature, they can cool the blood and stop bleeding, and clear liver fire. The lungs open into the nose, and nasal diseases are also related to liver fire invading the lungs. Sophora japonica flowers can clear heat from the liver and lungs, and cool the blood to prevent heat from damaging the blood vessels and causing nosebleeds.

[0028] Polygonatum: sweet and neutral in nature, it functions to replenish qi and nourish yin. This formula mainly contains pungent, drying, or bitter and cold herbs, which can easily deplete qi and yin with prolonged use. The addition of Polygonatum is like adding a logistics officer to an attacking force, which can counteract the drying and drying properties of the other herbs and prevent them from damaging the vital qi and body fluids of the nasal passages. This reflects the wisdom of traditional Chinese medicine in "attacking the pathogenic factors without harming the body's vital energy."

[0029] Guiding herbs – acting as guides and agents, harmonizing the effects of other herbs; Kudzu flower: sweet and neutral in nature, traditionally used to detoxify alcohol, invigorate the spleen and stomach. Its light and ascending properties are used in this formula to guide the medicine upwards, allowing its effects to reach the head, face, and nasal passages more effectively.

[0030] Edible leaves: Cool in nature, with effects of clearing heat and detoxifying, and promoting bowel movements. In this formula, its "clearing and detoxifying" properties are likely utilized, along with its laxative properties, to help expel toxins. It assists other herbs in clearing heat and also has a certain harmonizing effect.

[0031] The formulation of this prescription is based on a clear and rigorous approach. With soapberry and musk as the vanguard (chief), they swiftly open the blocked nasal passages; with saposhnikovia, angelica, magnolia and coptis as the main force (minister), they follow closely behind, dispelling wind, draining pus, clearing heat, and eliminating pathogenic factors; with catechu, perilla, sophora, and polygonatum as the supporting (assistant), catechu is responsible for repair, perilla and sophora work together, and polygonatum provides logistical support to prevent self-harm; with kudzu flower and edible leaves as messengers (messengers), they guide the medicinal power and harmonize the various herbs.

[0032] This formula works synergistically to dispel wind and open the orifices, clear heat and remove dampness, detoxify and drain pus, while also protecting the body's vital energy. It is a versatile external formula that combines both offensive and defensive effects.

[0033] Compared with the prior art, the beneficial effects of the present invention are: 1. Pharmacokinetic study data of the present invention prove that the composition of the present invention can reduce nasal symptoms to varying degrees, reduce serum IL-4, IL-13 and IgE levels in rats, and reduce eosinophils and neutrophils in nasal mucosa tissue, thus having a good effect on improving nasal abnormalities.

[0034] 2. Clinical efficacy of the present invention has demonstrated that patients treated with the composition of the present invention can effectively reduce the TCM syndrome score, serum total IgE (U / mL) cytokines, serum Th9 cytokines, inflammatory factors IL-4, IL-6, and TNF-α levels, and increase serum cytokine Treg levels, with a high overall effective rate and no adverse reactions.

[0035] 3. Compared with the comparative formulation, the drug synergistic effect between the drugs in the traditional Chinese medicine composition of the present invention is stronger and the therapeutic effect is better. Attached Figure Description

[0036] Figure 1 This is a process flow diagram of ultrafine grinding and grading screening in Embodiment 1 of the present invention. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0038] The weight ratio of the present invention represents the mass ratio, where part is a unit of weight, and both are in g or kg.

[0039] Example 1 A traditional Chinese medicine composition for treating rhinitis, the formula and proportions by weight are as follows: 10 parts of soapberry, 0.3 parts of artificial musk, 9 parts of saposhnikovia root, 9 parts of angelica root, 9 parts of magnolia flower, 8 parts of coptis root, 8 parts of catechu, 6 parts of perilla leaf, 8 parts of sophora flower, 8 parts of polygonatum rhizome, 3 parts of kudzu flower, and 3 parts of edible leaf herb.

[0040] Preparation method: The raw medicinal materials are dried at low temperature and preliminarily pulverized. All the medicinal materials are pulverized to a target particle size of ≥800 mesh (800 mesh is about 18 micrometers) by ultra-micro pulverization. The materials are graded and screened to select medicinal powder in the range of 45-150μm. The medicinal powder is mixed and homogenized according to the above proportion and sterilized to obtain the traditional Chinese medicine composition of the present invention.

[0041] The finished powder produced by this invention is inhaled through the nasal cavity. Utilizing the powder's physical hygroscopicity and mucosal adsorption properties, it quickly absorbs excess nasal mucus (snot), while simultaneously delivering the medicinal components directly and persistently to the nasal mucosa. It provides a drier feel and may have a longer-lasting effect, making it suitable for users who particularly dislike a "wet" feeling or have excessive nasal discharge.

[0042] As a preferred example, the detailed steps and control parameters of the process of this invention are as follows. The specific scheme below is only one way to select medicinal powder in the range of 45-150μm, and is not the only way.

[0043] Step 1: Primary grinding and drying Equipment: Universal pulverizer, hammer mill.

[0044] Objective: To initially pulverize all medicinal materials to ≥800 mesh.

[0045] Key control points: Low-temperature operation: The pulverizer needs to be connected to a cooling device (such as circulating water cooling) to ensure that the temperature of the pulverizing chamber is always ≤40℃. This prevents the loss of volatile components (such as the aromatic oils of musk, angelica, and perilla) and the gelatinization of the material due to high temperatures.

[0046] Moisture control: All raw materials must be dried at a low temperature (≤60℃) before pulverization to ensure a moisture content of ≤8%. Dry materials are easier to pulverize and can effectively prevent subsequent clogging and agglomeration.

[0047] Step 2: Ultrafine grinding and classification (process flow diagram as follows) Figure 1 (As shown) Equipment: Air jet mill with air classifier.

[0048] Objective: To initially pulverize all medicinal materials to ≥800 mesh.

[0049] Principle: High-speed airflow drives the material to collide and crush, and the centrifugal force generated by the classifying wheel separates and discharges the excessively fine "dangerous particles".

[0050] 1-Remove overly coarse particles: Return coarse particles >150μm directly to the pulverizer for further pulverization.

[0051] 2-Remove excessively fine particles: Separate "dangerous fine powder" <10μm and use it as waste or for other purposes.

[0052] 3-Collect qualified particles: Only "qualified particles" in the range of 45-150μm will be output as finished powder.

[0053] Process parameters for ultrafine grinding: Grading wheel frequency: 18-25Hz. The higher the frequency, the greater the centrifugal force, and the coarser the particles allowed to pass through. Precise fine-tuning is required based on real-time monitoring results.

[0054] Feed rate: 3-5 kg / h. Maintaining a uniform and stable feed is a prerequisite for obtaining a stable particle size distribution.

[0055] Crushing pressure: 0.7-0.8 MPa. Ensure sufficient kinetic energy for effective crushing.

[0056] Step 3: Mixing and Homogenizing Equipment: Three-dimensional motion mixer.

[0057] Key process parameters: Mixing time: 30-60 minutes. Too short a time will result in uneven mixing, while too long a time may cause secondary breakage or stratification of the particles.

[0058] Loading factor: 60%-70%. This refers to the volumetric loading rate of the mixer, within which mixing efficiency is highest.

[0059] Step 4: Sterilization and Terminal Control Method: Sterilization by cobalt-60 gamma ray irradiation.

[0060] Dosage: 8-10 kGy. This dosage is effective in killing bacteria and fungi without significantly affecting the physicochemical properties of the powder.

[0061] Terminal quality control: Each batch of finished product must be tested using a laser particle size analyzer, and a report must be issued to ensure that the particle size falls within the range of 45-150μm. Microbial limit tests are also performed to ensure compliance with the "Cosmetic Safety Technical Specifications" or pharmaceutical standards.

[0062] Comparative Example 1 A traditional Chinese medicine composition, the formula and weight ratio of which are: 10 parts of Gleditsia sinensis, 9 parts of Saposhnikovia divaricata, 9 parts of Angelica dahurica, 8 parts of Catechu, and 3 parts of Pueraria lobata. The preparation method is the same as in Example 1.

[0063] Comparative Example 2 A traditional Chinese medicine composition, the formula and weight proportions of which are as follows: 10 parts of Gleditsia sinensis, 9 parts of Saposhnikovia divaricata, 9 parts of Angelica dahurica, 9 parts of Magnolia biondii, 8 parts of Coptis chinensis, 8 parts of Catechu, 8 parts of Sophora japonica, and 3 parts of Pueraria lobata. The preparation method is the same as in Example 1.

[0064] Example 2 Animal pharmacodynamic experimental data Effects of the traditional Chinese medicine composition of Example 1 and the comparative traditional Chinese medicine composition on a rat model of rhinitis 1. Experimental objective: This experiment investigated the therapeutic effect of the composition of Example 1 on rats with rhinitis by replicating a rat model of rhinitis, providing a pharmacological basis for the clinical application of the composition of Example 1.

[0065] 2. Test materials: Test substance (test sample): The composition of Example 1 (Hunan Yunlu Qingyuan Biotechnology Co., Ltd.), the composition of Comparative Example 1 (Hunan Yunlu Qingyuan Biotechnology Co., Ltd.), the composition of Comparative Example 2 (Hunan Yunlu Qingyuan Biotechnology Co., Ltd.), the intended route of clinical use: nasal spray, once a day on each side, 2 puffs each time, the intended course of clinical treatment: 14 days, positive control group, name: mometasone furoate nasal spray (Nasonex); experimental animals: 78 male SPF grade SD rats, weight range: 210-230g.

[0066] Main reagents: ovalbumin (OVA) and aluminum hydroxide Al(OH)3 were purchased from Sigma-Aldrich, USA. Modeling Method: Seventy-eight male SD rats were randomly divided into six groups: blank control group, model control group, comparative example 1, comparative example 2, example 1, and positive control group, with 13 rats in each group. After one week of acclimatization, except for the blank control group, the other rats were sensitized by intraperitoneal injection of 0.3 mg OVA + 30 mg Al(OH)3 mixed in 1 mL of physiological saline on days 1, 3, 5, 7, 9, 11, and 13. Nasal provocation began on day 15, with 50 μL of OVA (100 μg / 100 μL) instilled into each nostril for enhanced sensitization, and this was continued for 7 days. The blank control group rats received the same volume of physiological saline via intraperitoneal injection and nasal instillation.

[0067] After the final modeling, the behaviors of sneezing, nose scratching, and runny nose in each group of rats were observed within 30 minutes. Sneezing 1-3 times, 4-10 times, and ≥11 times were scored as 1, 2, and 3 points respectively; nose scratching 1-5 times, 6-15 times, and ≥16 times were scored as 1, 2, and 3 points respectively; and runny nose reaching the anterior nasal cavity, runny nose exiting the anterior nasal cavity, and runny nose covering the face were scored as 1, 2, and 3 points respectively. The scores of each item were added together to obtain the total score, and a total score >5 indicated successful modeling.

[0068] Administration method: The clinically intended dose of the compositions of Example 1, Comparative Examples 1 and 2 is 400 μg / day, which is converted to the clinically equivalent dose for rats based on body surface area = adult dose × 0.018 × 5 = 36 μg / kg. The dose of mometasone furoate nasal spray (Nasonex) (positive control group) is set at 36 μg, containing 18 μg mometasone furoate / kg. The positive control group was given mometasone furoate nasal spray (Nasonex) at a dose of 18 μg / kg per nostril, once a day. Comparative Examples 1, 2, and 1 were given nasal spray at a dose of 18 μg / kg per nostril, once a day. The blank control group and the model control group were given an equal volume of physiological saline nasal spray for 14 consecutive days.

[0069] Behavioral observation of nasal symptoms in rats of each group: After drug intervention, the scores of sneezing, nose scratching and runny nose in rats of each group within 30 minutes were counted.

[0070] Serum IL-4, IL-13, and IgE levels were detected by ELISA: Before sacrificing rats, 2 mL of venous blood was drawn from their tails and centrifuged at 3000 r / min for 15 min. The supernatant serum was separated and the serum levels were detected by ELISA. The procedure was strictly performed in accordance with the relevant standards of the kit.

[0071] HE staining and optical microscopic observation of nasal mucosa tissue: The heart was exposed by intraperitoneal injection of 10% chloral hydrate (100 μL / g), and physiological saline was perfused into the left ventricle. The nasal cavity was opened by the midline suture of the nasal dorsum, and the lower nasal mucosa tissue was dissected, fixed with 10% paraformaldehyde, serially paraffin sections were prepared, stained with HE, and the changes in the tissue structure of rat nasal mucosa specimens were observed under an optical microscope. Eosinophil and neutrophil counts were performed under a 40x objective.

[0072] Results Calculation and Statistics SPSS 21.0 software was used for statistical analysis. Experimental data are expressed as mean ± standard deviation (x±S). For comparisons among multiple groups, normality and homogeneity of variance were first compared. If the variances were homogeneous and normality was observed, one-way ANOVA was used. If normality was not observed, the Nonparametric T-test was used. If normality was observed but variances were unequal, Tamhane's T² test was used. If normality was not observed, the Kruskal-Wallis test was used. Pairwise comparisons were performed using the Mann-Whitney test. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly significant.

[0073] 4. Experimental Results Impact on the symptom behavior of large nasal cavity As shown in Table 1, compared with the blank control group, the nasal symptom behavior score of the model control group was significantly increased (P<0.01); compared with the model control group, the nasal symptom behavior scores of rats in Comparative Example 1, Comparative Example 2, Example 1, and Positive Control Group were all significantly decreased (P<0.05 or P<0.01); the nasal symptom behavior score of Example 1 was significantly lower than that of Comparative Example 1 and Comparative Example 2 (P<0.05 or P<0.01), the nasal symptom behavior score of Example 1 was significantly lower than that of the Positive Control Group (P<0.05), and the nasal symptom behavior score of Comparative Example 2 was significantly lower than that of Comparative Example 1 (P<0.05). The results are shown in Table 1.

[0074] Table 1 Comparison of behavioral scores for nasal cavity symptoms in each group ( )

[0075] Note: Compared with the blank control group, "**" indicates P<0.01; compared with the model control group, "**" indicates P<0.01. " indicates P < 0.05, " " " indicates P < 0.01, compared with Comparative Example 1; "#" indicates P < 0.05; "##" indicates P < 0.01, compared with Comparative Example 2; "▲" indicates P < 0.05, compared with the positive control group; "a" indicates P < 0.05.

[0076] Effects of serum IL-4, IL-13 and IgE levels in rats As shown in Table 2, compared with the blank control group, the levels of IL-4, IL-13, and IgE in the model control group rats were significantly increased (P<0.01); compared with the model control group, the levels of IL-4, IL-13, and IgE in Comparative Example 1, Comparative Example 2, Example 1, and the positive control group rats were significantly decreased (P<0.05 or P<0.01); compared with Comparative Example 1 and Comparative Example 2, the levels of IL-4, IL-13, and IgE in Example 1 were significantly decreased (P<0.05 or P<0.01); compared with the positive control group, the levels of IL-4 and IgE in Example 1 were significantly decreased (P<0.05), and IL-13 was decreased, but not statistically significant (P>0.05); compared with Comparative Example 1, the levels of IL-4 and IgE in Comparative Example 2 were significantly decreased (P<0.05), and IL-13 was decreased, but not statistically significant (P>0.05). The results are shown in Table 2.

[0077] Table 2 Comparison of serum IL-4, IL-13, and IgE levels in rats from different groups ( (n=13)

[0078] Note: Compared with the blank control group, "**" indicates P<0.01; compared with the model control group, "**" indicates P<0.01. " indicates P < 0.05, " " " indicates P < 0.01, compared with Comparative Example 1; "#" indicates P < 0.05; "##" indicates P < 0.01, compared with Comparative Example 2; "▲" indicates P < 0.05; "▲▲" indicates P < 0.01, compared with the positive control group; "a" indicates P < 0.05.

[0079] Effects on eosinophils and neutrophils in rat nasal mucosa As shown in Table 3, compared with the blank control group, the number of eosinophils and neutrophils in the nasal mucosa of rats in the model control group was significantly increased (P<0.01); compared with the model control group, the number of eosinophils and neutrophils in rats in Comparative Example 1, Comparative Example 2, Example 1, and Positive Control Group was significantly decreased (P<0.05 or P<0.01); compared with Comparative Example 1 and Comparative Example 2, the number of eosinophils and neutrophils in Example 1 was significantly decreased (P<0.05 or P<0.01); compared with the positive control group, the number of eosinophils in Example 1 was significantly decreased (P<0.05), and the number of neutrophils was decreased, but not statistically significant (P>0.05); compared with Comparative Example 1, the number of eosinophils in Comparative Example 2 was significantly decreased (P<0.05), and the number of neutrophils was decreased, but not statistically significant (P>0.05). The results are shown in Table 3.

[0080] Table 3 Comparison of eosinophil and neutrophil counts in the nasal mucosa of rats in each group (Unit: 10⁹ / L) (n=13)

[0081] Note: Compared with the blank control group, "**" indicates P<0.01; compared with the model control group, "**" indicates P<0.01. " indicates P < 0.05, " " " indicates P < 0.01, compared with Comparative Example 1; "#" indicates P < 0.05; "##" indicates P < 0.01, compared with Comparative Example 2; "▲" indicates P < 0.05; "▲▲" indicates P < 0.01, compared with the positive control group; "a" indicates P < 0.05.

[0082] Conclusion: Under the conditions of this experiment, the compositions of Comparative Example 1, Comparative Example 2, and Example 1 can reduce nasal symptoms and behaviors to varying degrees, reduce serum IL-4, IL-13, and IgE levels in rats, and reduce eosinophils and neutrophils in nasal mucosa tissue. Example 1 is more effective than Comparative Example 1 and Comparative Example 2. The synergistic effect of the drugs in Example 1 is more significant than that in Comparative Example 1 and Comparative Example 2.

[0083] Example 3: Clinical analysis data of the traditional Chinese medicine composition from Example 1 126 patients meeting the criteria for allergic rhinitis were selected as the study subjects and randomly divided into Example 1 and a control group. Example 1 consisted of 38 males and 25 females, aged 22–46 years (mean age 33.56±4.87 years), with a disease duration of 2–6 years. The control group consisted of 36 males and 27 females, aged 23–47 years (mean age 34.12±4.98 years), with a disease duration of 2–6 years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0084] Inclusion criteria: meeting the Western medicine diagnostic criteria for allergic rhinitis (AR) in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)"; and being between 20 and 50 years of age.

[0085] Exclusion criteria: Those with a history of using anti-allergy medications, immunosuppressants, or glucocorticoids within the past month; those with concurrent dysfunction of vital organs such as the liver, kidneys, and lungs; those with malignant tumors or serious infectious diseases; those with coagulation disorders and bleeding tendencies; women who are planning to conceive, pregnant, or breastfeeding; those with a history of nasal surgery; and those with severe mental illness.

[0086] Treatment methods: The reference drug is mometasone furoate nasal spray (Nasonex), whose main ingredient is mometasone furoate. Specifications: 60 puffs, 100ug / puff, containing 50ug mometasone furoate / puff, nasal spray, 2 puffs per nostril (each puff is 50ug mometasone furoate), once a day (total amount is 200ug mometasone furoate), for 14 consecutive days; Example 1 product (Hunan Yunlu Qingyuan Biotechnology Co., Ltd.), nasal spray, 2 puffs per nostril (each puff is 100ug), once a day (total amount is 400ug), for 14 consecutive days.

[0087] Observation indicators and efficacy evaluation criteria 1. Clinical Efficacy. Efficacy Judgment Criteria: Marked efficacy is defined as the complete disappearance of clinical symptoms such as nasal itching, runny nose, and sneezing; normal nasal ventilation; a rosy nasal mucosa color upon instrumental examination; no nasal secretions; and complete restoration of normal smell. Effective efficacy is defined as some improvement or disappearance of the above symptoms; a dark red nasal mucosa; and some improvement in olfactory dysfunction. Ineffective efficacy is defined as failure to meet the above criteria or even worsening of symptoms. Total effective rate = (Number of markedly effective cases + Number of effective cases) / Total number of cases × 100%.

[0088] 2. Traditional Chinese Medicine (TCM) syndrome score. Referring to the scoring criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial Implementation)," the scores of symptoms such as nasal congestion, runny nose, nasal itching, and sneezing of the two groups of patients before and after treatment were evaluated. No symptoms were scored as 0 points, mild symptoms as 1-2 points, moderate symptoms as 3-4 points, and severe symptoms as 5-6 points. The higher the score, the more severe the patient's symptoms.

[0089] 3. Serum cytokine levels. Before and after treatment, 3 mL of venous blood was collected from the patients, and the serum was separated (rotation speed: 3500 r / min; time: 10 min). The serum total immunoglobulin E level was measured using a fully automated immunoassay analyzer; regulatory T cells (Treg) and helper T cells 9 (Th9) were detected by flow cytometry.

[0090] 4. Inflammatory factor levels. Before and after treatment, 3 mL of fasting venous blood was collected from the patients, placed in anticoagulant tubes, and centrifuged (speed: 3500 r / min; time: 10 min). The levels of interleukin-4 (IL-4), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were detected using an automated microplate reader combined with enzyme-linked immunosorbent assay.

[0091] (5) Occurrence of adverse reactions.

[0092] Statistical methods: SPSS 22.0 statistical software was used for data processing and analysis in this study. The t-test was used to compare continuous data, and the chi-square test was used to compare categorical data. P < 0.05 was considered statistically significant.

[0093] Table 4 Comparison of clinical efficacy between the two groups of patients [n(%)]

[0094] Note: Compared with the pre-treatment values ​​in this group, "*" indicates P<0.05.

[0095] Table 5 Comparison of TCM syndrome scores before and after treatment in the two groups of patients

[0096] Note: Compared with the group before treatment, "*" indicates P<0.05, "**" indicates P<0.01; compared with the control group after treatment, "#" indicates P<0.05, "##" indicates P<0.01.

[0097] Table 6 Comparison of serum cytokine levels before and after treatment in the two groups of patients

[0098] Note: Compared with the group before treatment, "*" indicates P<0.05, "**" indicates P<0.01; compared with the control group after treatment, "#" indicates P<0.05.

[0099] Table 7 Comparison of inflammatory factor levels before and after treatment in the two groups of patients.

[0100] Note: Compared with the group before treatment, "*" indicates P<0.05, "**" indicates P<0.01; compared with the control group after treatment, "#" indicates P<0.05.

[0101] Table 8 Comparison of adverse reaction occurrences between the two groups of patients [cases (%)]

[0102] Note: Compared with the pre-treatment values ​​in this group, "*" indicates P<0.05. As shown in Tables 4-8, the TCM syndrome scores, serum cytokine levels, and inflammatory factor levels of the two groups before and after treatment were compared: Before treatment, there were no statistically significant differences in TCM syndrome scores, serum cytokine levels, and inflammatory factor levels between the two groups (P>0.05); After treatment, the TCM syndrome scores, serum cytokine levels, and inflammatory factor levels of both groups were significantly better than before treatment (P<0.05 or P<0.01); The TCM syndrome scores, serum cytokine levels, and inflammatory factor levels of the Example 1 group after treatment were significantly better than those of the control group (P<0.05 or P<0.01); Adverse reaction observation and comparison: The incidence of adverse reactions in the Example 1 group after treatment was lower than that in the control group (P<0.05); Clinical efficacy comparison: The effective rate of the Example 1 group was higher than that of the control group (P<0.05).

[0103] Example 4 A traditional Chinese medicine composition for treating rhinitis, comprising the following ingredients and proportions by weight: 8 parts of Gleditsia sinensis, 0.1 parts of artificial musk, 11 parts of Saposhnikovia divaricata, 11 parts of Angelica dahurica, 10 parts of Magnolia biondii, 7 parts of Coptis chinensis, 8 parts of catechu, 7 parts of Perilla frutescens, 8 parts of Sophora japonica, 9 parts of Polygonatum sibiricum, 4 parts of Pueraria lobata, and 1 part of Artemisia annua. The preparation method is the same as in Example 1.

[0104] Experiments have shown that the traditional Chinese medicine composition of Example 4 has no obvious toxic side effects and its efficacy is similar to that of Example 1. The experimental data will not be repeated here.

[0105] The detailed description of the embodiments of the present invention provided above is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating rhinitis, characterized in that, The active ingredients and their weight ratios in the traditional Chinese medicine composition are as follows: 5-15 parts of Gleditsia sinensis, 0.1-0.5 parts of artificial musk, 6-13 parts of Saposhnikovia divaricata, 7-14 parts of Angelica dahurica, 8-12 parts of Magnolia biondii, 6-10 parts of Coptis chinensis, 8-10 parts of Catechu, 4-8 parts of Perilla frutescens, 7-10 parts of Sophora japonica, 7-10 parts of Polygonatum sibiricum, 1-5 parts of Pueraria lobata, and 1-4 parts of Citrus reticulata. The raw medicinal materials are dried at low temperature and preliminarily pulverized. All the medicinal materials are then pulverized again by ultra-micro pulverization, graded and screened, and the powders in the range of 45-150μm are selected. The powders are mixed and homogenized according to the above proportions, sterilized, and made into a topical powder or spray for rhinitis, wherein the rhinitis is allergic rhinitis.

2. The traditional Chinese medicine composition for treating rhinitis according to claim 1, characterized in that: The medicinal components and their weight ratios in the traditional Chinese medicine composition are as follows: 10 parts of Gleditsia sinensis, 0.3 parts of artificial musk, 9 parts of Saposhnikovia divaricata, 9 parts of Angelica dahurica, 9 parts of Magnolia biondii, 8 parts of Coptis chinensis, 8 parts of catechu, 6 parts of Perilla frutescens, 8 parts of Sophora japonica, 8 parts of Polygonatum sibiricum, 3 parts of Pueraria lobata, and 3 parts of Artemisia annua.

3. The traditional Chinese medicine composition for treating rhinitis according to claim 1, characterized in that, The active ingredients and their weight ratios in the traditional Chinese medicine composition are as follows: 8 parts of Gleditsia sinensis, 0.1 parts of artificial musk, 11 parts of Saposhnikovia divaricata, 11 parts of Angelica dahurica, 10 parts of Magnolia biondii, 7 parts of Coptis chinensis, 8 parts of catechu, 7 parts of Perilla frutescens, 8 parts of Sophora japonica, 9 parts of Polygonatum sibiricum, 4 parts of Pueraria lobata, and 1 part of Lysimachia christinae.

4. The traditional Chinese medicine composition for treating rhinitis according to claim 1, characterized in that, The raw materials are first dried at a low temperature of ≤60℃, and then initially pulverized at a temperature of ≤40℃.

5. The traditional Chinese medicine composition for treating rhinitis according to claim 1, characterized in that, The control parameters for ultrafine grinding include: ultrafine grinding under the conditions of a classifier wheel frequency of 18-25Hz, a feed rate of 3-5kg / h, and a grinding pressure of 0.7-0.8MPa.

6. The traditional Chinese medicine composition for treating rhinitis according to claim 1, characterized in that, The control parameters for mixing and homogenization include: loading coefficient 60%-70%, mixing time: 30-60 minutes.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a drug for treating rhinitis, wherein the rhinitis is allergic rhinitis.

Images